Study of Pro-inflammatory Cytokines in Case of Essure® Contraceptive Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- cytokine IL10 in peritoneal fluid
研究概览
简要总结
It is estimated that 750,000 women (including 200,000 French) have benefited from permanent sterilization by ESSURE® contraceptive implant. The observation in some of these patients of gynecological and extra-gynecological symptoms leads to the surgical removal of these implants.
The pathophysiological mechanism(s) is (are) not yet determined. Several pathophysiological hypotheses have been proposed, in particular the inflammatory hypothesis. The investigators propose to study markers of inflammation (pro-inflammatory cytokines) in peritoneal fluid and blood. Cytokines are involved in the physiopathology of autoimmune diseases, infectious pathologies, or even cancer; they are used in everyday practice and can constitute a therapeutic target.
Based on the literature which finds a high concentration of cytokines in cases of endometriosis, and a low concentration in healthy control patients, the investigators want to assess inflammation in patients with Essure® implants.
The demonstration of one or more specifically increased cytokines in the Essure® group could validate the inflammatory hypothesis and lead to the implementation of specific treatments and relevant markers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women over 18
- •intervention between January 2021 and November 2022
- •person having expressed his non-opposition
- •Essure group : patient who underwent removal of the Essure® contraceptive implant
- •Control with no endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with no diagnosis of endometriosis or adenomyosis
- •Control with endometriosis/adenomyosis : patient who underwent benign laparoscopic gynecological surgery and with diagnosis of endometriosis or adenomyosis
排除标准
- •inability to understand the information given
- •person deprived of liberty
- •person under guardianship
结局指标
主要结局
cytokine IL10 in peritoneal fluid
时间窗: through study completion, an average of 4 months
Level of cytokine IL10 in peritoneal fluid
次要结局
未报告次要终点
